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Showing 1361–1380 of 68218 results

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MediHoney Paste (Integra) – packaging failure (2025)

Packaging failures were identified which could lead to a breach in the sterile barrier.

Moderate

FDAAug 5, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

Ramen Noodles (Kobayashi) – Undeclared Soy (2025)

Ramen Noodle package label does not declare Soy as the source for lecithin ingredient.

Class IIModerate

FDAAug 5, 2025CA• Kobayashi Noodle U.S.A.

DxC 500 Analyzer (Beckman Coulter) – test processing issue (2025)

On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.

Moderate

FDAAug 4, 2025Nationwide• Beckman Coulter Inc.

Raman Spectrometers (Wasatch Photonics) – laser safety (2025)

Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur in these models, whether in the field or factory, but could potentially occur under excessive force or extreme, continuous vibration.

Moderate

FDAAug 4, 2025Nationwide• WASATCH PHOTONICS

PhD Hemostasis Valve (Merit Medical) – manufacturing defect (2025)

Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

Moderate

FDAAug 4, 2025AL, AK, AZ +47 more• Merit Medical Systems, Inc.

Halyard CPT Basic IR Pack (AVID Medical) – seal compromise (2025)

Potential for open header bag seals, compromising sterility.

Low

FDAAug 4, 2025Nationwide• AVID Medical, Inc.

Novum IQ Large Volume Pump (Baxter) – device correction (2025)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

Moderate

FDAAug 4, 2025PR• Baxter Healthcare Corporation

Novum IQ Syringe Pump (Baxter) – device correction (2025)

Moderate

FDAAug 4, 2025PR• Baxter Healthcare Corporation

Epinephrine Injection (Pfizer) - Sterility Issue (2025)

Lack of Assurance of Sterility.

Class IIModerate

FDAAug 4, 2025Nationwide• PFIZER INC

Halyard ENT Pack (AVID Medical) – seal compromise (2025)

Potential for open header bag seals, compromising sterility.

Low

FDAAug 4, 2025Nationwide• AVID Medical, Inc.

Lactated Ringer's Injection (B Braun) - Sterility Concern (2025)

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Class IIModerate

FDAAug 4, 2025Nationwide• B BRAUN MEDICAL INC

Potato Salad (Hans Kissle) – Undeclared Wheat (2025)

Undeclared Gluten

Contains undeclared wheat. The top label identifies the product as potato salad, but the unit contains pasta salad.

Class IIModerate

FDAAug 4, 2025CT, MA, NJ +2 more• Hans Kissle Company, LLC

Sodium Chloride Injection (B Braun) - Sterility Concern (2025)

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Class IIModerate

FDAAug 4, 2025Nationwide• B BRAUN MEDICAL INC

Sodium Bicarbonate Injection (Pfizer) - Sterility Issue (2025)

Lack of Assurance of Sterility.

Class IIModerate

FDAAug 4, 2025Nationwide• PFIZER INC

Belgian Chocolates (Neuhaus) – Undeclared Wheat (2025)

Undeclared Gluten

Product contains undeclared wheat.

Class IHigh

FDAAug 4, 2025MD, NY, PA +3 more• Neuhaus nv

Azurion System (Philips) – power supply issue (2025)

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

Moderate

FDAAug 1, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura Xper X-Ray System (Philips) – component missing (2025)

Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

Low

FDAAug 1, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura System (Philips) – power supply issue (2025)

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

Moderate

FDAAug 1, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Granulated Onion (PAX Spices) – Metal Contamination (2025)

Foreign object (metal) in granulated onion ingredient.

Class IIModerate

FDAAug 1, 2025Nationwide• PAX Spices & Labs Inc

Vanilla Bean Ice Cream (Friendly's) – Undeclared Allergens (2025)

Undeclared Gluten

Product contains undeclared wheat and soy.

Class IIModerate

FDAAug 1, 2025MD, PA, VA• DFA Dairy Brands, LLC

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